5 Reasons why the FDA got it Right with Digital Health

The FDA recently announced its Digital Health Innovation Action Plan. This plan was both important and necessary. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. Digital health software technologies have far less involvement by clinicians in product development than Pharma or medical device companies. Innovation and improvements in digital health occur at lightning speed in comparison to other FDA regulated industries and require different approval and oversight strategies (see below). Multifunctional digital health technology interacting with both drugs and devices creates a need for a new agency framework and workflow for such combined products. The Action Plan is a major step in the right direction because it recognizes digital healths unique attributes which span both IT and clinical arenas. In addition it recognizes the need for infrastructural and process changes in the agency itself. It will address lingering issues such as multifunctional software (technology which has software qualifying as a medical device combined with that which doesnt).